An interventional study of Operative hysteroscopy using tissue removal device and suction curettage in Early Abortion and Pregnancy Loss, Early, sponsored by Assaf-Harofeh Medical Center. Recruiting at 2 sites in Israel. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment
Early pregnancy loss occurs in \~15% of pregnancies. The treatment options include surgical uterine evacuation by suction curettage, medical management with misoprostol, or conservative management without interventions. The advantages of surgical management include quick resolution of the pregnancy and avoidance of heavy vaginal bleeding, while the disadvantages include retained products of conception and intrauterine adhesion formation which could affect future fertility. With the aim of reducing the complications of suction curettage, uterine evacuation using operative hysteroscopy has been suggested.
In a previous study, the investigators compared suction curettage with operative hysteroscopy for the surgical management of early pregnancy loss up to 10 weeks of gestation. The results showed significantly reduced adhesions rate (4.2% in the hysteroscopy group vs. 45.2% in the suction group, p \< 0.01), although the operative time was significantly longer for the hysteroscopy.
In this follow-up study, the investigators will compare the outcomes of hysteroscopy and suction curettage in a select group of patients with early pregnancy loss following conception by in-vitro fertilization. These patients are at risk for adhesions and therefore candidates for the hysteroscopic intervention. The study will include 50 patients randomized to 2 intervention arms - hysteroscopy using a tissue removal device versus the standard suction curettage. Post-operative adhesions will be assessed by office hysteroscopy after 6-8 weeks.
The treatment options for early pregnancy loss include surgical uterine evacuation by suction curettage, medical management with misoprostol, and expectant (conservative) management. The advantages of surgical evacuation include quick resolution of the pregnancy and prevention of heavy bleeding that could necessitate urgent curettage. Although suction curettage is a common and relatively safe procedure, it carries short term risks such as infection, retained products of conception requiring repeat surgery, hemorrhage, and uterine perforation. Long term complications include intrauterine adhesions (also known as Asherman's syndrome), which may impair fertility. In recent years, the option of uterine evacuation by operative hysteroscopy has been investigated. Hysteroscopy enables a visual inspection of the uterine cavity (as opposed to the blind suction curettage), and involves a targeted and limited contact with the endometrium, possibly reducing adhesion formation compared to the "global" suction curettage.
Previous studies indeed found that hysteroscopy was feasible and safe for the surgical management of early pregnancy loss. The investigators recently completed a prospective RCT comparing suction curettage and operative hysteroscopy in 100 women diagnosed with early pregnancy loss up to 10 weeks of gestation. The results showed a significantly lower rate of intrauterine adhesions in the hysteroscopy group (4.2% vs. 45.2%, p \< 0.01). However, operative time was significantly longer for the hysteroscopy. There were no significant differences between groups in the rates of retained products of conception or surgical complications.
Although the study did not address the cost of the different surgical techniques, hysteroscopy is obviously more expensive and requires specialized equipment and skilled surgeons. Thus, operative hysteroscopy is likely more applicable for selected patients at risk for intrauterine adhesions and impaired fertility.
Patients undergoing in-vitro fertilization (UVF) represent a unique population with higher baseline risk for intrauterine adhesions due to prior uterine procedures and repeated curettage. Hooker et al. demonstrated that adhesions could cause impair embryo implantation, thereby reducing the rate of successful IVF cycles. Deng et al. showed that delaying embryo transfer after adhesiolysis improves live birth rates.
In view of the impact of adhesions on fertility and the potential to delay pregnancy, selecting the optimal surgical method is especially important for IVF patients diagnosed with early pregnancy loss, and these patients may benefit specifically from the hysteroscopic procedure.
This study is a randomized controlled, non-blinded study interventional study comparing operative hysteroscopy and suction curettage for the surgical management of early pregnancy loss in patients undergoing in-vitro fertilization. The study will include 50 patients (25 in each arm) diagnosed with early pregnancy loss ≤10 weeks. The study will compare procedural feasibility, safety, postoperative intrauterine adhesions and retained products of conception, as well as time to the next pregnancy.
221 studies on the registry are indexed under Abortion, Spontaneous; 44 are open to participants now.
This study's planned enrollment of 50 is below the median of 150 across 120 interventional studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Operative hysteroscopy using tissue removal device
Device: Operative hysteroscopy using tissue removal device
Standard suction curettage
Device: suction curettage
Operative hysteroscopy using tissue removal device
suction curettage using plastic scution curette
Intrauterine adhesions
Post-operative intrauterine adhesions will be evaluated by office diagnostic hysteroscopy after 6-8 weeks. The physician performing the office hysteroscopy will be blinded to the patient's intervention arm. The intrauterine adhesions will be classified according to the American Fertility Society score (from 0 to 12, higher scores means worse adhesions).
Time frame: 8 weeks
Time to pregnancy
The patient's reproductive outcomes will be assessed by telephone interview after 6 and 12 months from the intervention.
Time frame: 12 months
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